Quadratus Lumborum in Cesarean Section Trial (QUALICS)
Comparison Between Intrathecal Morphine and Quadratus Lumborum Block for Postpartum Analgesia of Elective Cesareans.
Postoperative pain of a caesarean section may be of high intensity, especially in the first 48 hours after the procedure, which affects the mother / newborn relationship, in addition to having the potential to progress to chronic pain. The use of intrathecal morphine is effective in post-caesarean analgesia, but carries unwanted side effects, including nausea, vomiting, urinary retention and pruritus. Therefore, alternative techniques of analgesia become necessary.
First described in 2007, ultrasound-guided quadratus lumborum (QL) block has gained prominence due to its analgesic superiority to the TAP block. Besides providing somatic analgesia, it also seems to inhibit visceral pain because the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast medium injected at the QL block site.
연구 개요
상세 설명
C-section is one of the most performed surgical procedures in the world, and presents great potential for postoperative pain, especially in the first 48 hours. Pain in this period represents a risk for evolution to chronic pain, but its incidence is still very divergent when comparing the studies, ranging from 1% to 18%.
The use of intrathecal morphine (MIT) is consecrated as a first-choice method of analgesia for post-partum cesarean delivery; however, its use carries relevant side effects for the puerpera, such as pruritus, nausea, urinary retention and , more rarely, respiratory depression. In the last decade, new adjunctive forms of postoperative analgesia have become more popular, such as regional blockades, highlighting the blockage of the Transversus Abdominis plane block (TAP) and the Quadratus Lumborum block (QL), taking as benefits the prolonged analgesia they provide and the low incidence of side effects. Another factor that contributes to the popularization of regional blocks is the increasing availability of ultrasound devices in the anesthetic-surgical environment. Studies evaluating TAP block after cesarean section performed under spinal anesthesia have shown a discrete benefit in decreasing postoperative opioid consumption in addition to improving pain scores. When comparing MIT with TAP block, the superiority of MIT is due to visceral analgesia while TAP block is restricted to abdominal wall analgesia.
Ultrasound-guided Lumbar Quadrant blockade has gained prominence due to its analgesic superiority over the TAP block, because in addition to providing somatic analgesia it also seems to inhibit visceral pain since the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast injected at the site of the QL block.
Reviewing the literature in 2018, there are no clinical trials comparing the use of intrathecal morphine with the quadratus lumborum block.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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São Paulo, 브라질, 05403000
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Minimum age of 18 years
- Minimum gestational age of 37 weeks with a single fetus
- Patients scheduled for elective cesarean section
Exclusion Criteria:
- Clinical contraindication to spinal anesthesia
- Morbid obesity (BMI> 35kg / m²)
- Drug addiction
- Chronic use of opioids or benzodiazepines
- Inability to understand or handle the PCA pump
- Allergy to any medication included in the protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Classical spinal anesthesia
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + placebo quadratus lumborum block.
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Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
다른 이름들:
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실험적: Spinal anaesthesia with block
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg + quadratus lumborum block.
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Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
다른 이름들:
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실험적: Classical anaesthesia plus block
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + quadratus lumborum block.
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Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Morphine consumption
기간: 24 hours
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Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.
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24 hours
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Pain intensity
기간: 24 hours
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Verbal numeric scale
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24 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Nausea and Vomiting
기간: 24 hours
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Evaluate the incidence of nausea and vomiting between the groups through referred nausea scale from none, mild, moderate or severe.
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24 hours
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Pruritus
기간: 24 hours
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Evaluate the incidence of pruritus between the groups through pruritus referred scale from none, mild, moderate or severe.
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24 hours
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Chronic pain
기간: 3 months
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Evaluate the incidence of chronic pain between the groups through patient referred presence or absence of pain.
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3 months
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Urinary retention
기간: 24 hours
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Evaluate the incidence of urinary retention between the groups through patient referred presence or absence of urinary retention.
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24 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hermann S Fernandes, MD, University of Sao Paulo
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CAAE 90600818.0.0000.0068
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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